Double action infusion pump

ABSTRACT

An infusion system includes a double action infusion pump. The pump includes a cylinder and a reciprocating piston received within the cylinder, the reciprocating piston separating a first pump chamber from a second pump chamber of the cylinder. A reciprocating motor is coupled with the reciprocating piston, and the first and second pump chambers alternate between filling and evacuating conditions with reciprocation of the reciprocating piston through operation of the reciprocating motor, and the speed of reciprocation is varied to provide a continuous output of fluid between the first and second pump chambers. A fluid source and a catheter are optionally coupled with the double action infusion pump. The catheter includes one or more infusion ports near a catheter distal portion, and the one or more infusion ports receive and expel the continuous output of fluid from the double action infusion pump.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/822,871, filed Aug. 10, 2015, now U.S. Pat. No. 10,004,846; which isa continuation of U.S. application Ser. No. 13/794,528, filed Mar. 11,2013, now U.S. Pat. No. 9,107,986, the entirety of which areincorporated herein by reference.

TECHNICAL HELD

This document pertains generally, but not by way of limitation, toinfusion and contrast delivery systems.

BACKGROUND

Thrombectomy is a procedure for removing thrombus from the vasculature.Mechanical and fluid based systems are used to remove thrombus andaccordingly open clogged or partially clogged vessels. With fluid basedsystems an infusion fluid including one or more of saline, lytics andthe like is infused to a treatment area of a vessel with a catheter, forinstance a thrombectomy catheter. The hydrodynamic force of the infusionfluid and optionally the characteristics of the lytics dislodge thrombusand accordingly open the vessel.

In one example, the infusion fluid is delivered to the thrombectomycatheter in a pulsed manner with a pump including a single piston. Thepiston is moved in a first direction to draw fluid into a cylinder, andthen moved in a second direction to push the fluid out of the cylinderto a treatment feature of the thrombectomy catheter (e.g., an orifice).The pulses of fluid generated by the piston pump are thendiscontinuously applied through the treatment feature of thethrombectomy catheter to dislodge thrombus from the vessel wall.Optionally, the cylinder is prefilled with a fluid (e.g., contrast fluidor infusion fluid for thrombectomy) and the piston is driven in a singledirection to gradually infuse the fluid. Upon full delivery of the fluidthe cylinder must be refilled before operation is continued.

In another example a multi-cylinder pump including a plurality ofcorresponding pistons are coordinated to provide a continuous flow ofinfusion fluid. Stated another way, the plurality of pistons areoperated out of sync with one another to ensure that as one of thecylinders is filling with infusion fluid another of the cylinders isproviding infusion fluid output. A mechanism (e.g., a softwarealgorithm, mechanical mechanism or the like) is used to coordinate thepistons in this manner.

OVERVIEW

The present inventors have recognized, among other things, that aproblem to be solved can include providing a continuous flow of infusionfluid to a vessel (e.g., for thrombus removal, contrast injection or thelike) with a single reciprocating piston. Multi-piston pumps, when thepistons are coordinated, are able to provide continuous flow. However,coordinating algorithms or mechanical linkages are needed to sync thepistons and provide a continuous flow of fluid. Additionally,multi-piston pumps have a large volume to accommodate the plurality ofcylinders, pistons and operating mechanisms.

In an example, the present subject matter can provide a solution to thisproblem, such as by a double action infusion pump using a single pistonto provide fluid flow during reciprocation of the piston in first andsecond directions. Each of first and second pump chambers within thecylinder are alternately filled and evacuated with movement of a singlepiston. By varying the speed of the piston reciprocation (e.g., havingdifferent speeds in an intermediate segment of the cylinder and near topand bottom zones of the cylinder) the double action piston pump providesa continuous output of infusion fluid. The continuous output from thepump is delivered to one or more infusion ports of a catheter in oneexample, and the double action infusion pump thereby provides acontinuous infusion flow through the infusion ports. A single pistoninfusion pump with this arrangement is compact relative to multi-pistonpumps and readily configured for installation within a larger infusionsystem already configured for use of a single action reciprocatingpiston pump.

Furthermore, by varying a speed of the reciprocating piston from one endof an intermediate segment of the cylinder to the ends of the top orbottom zones (e.g., immediately prior to reversing movement of thepiston) the continuous output of the double action pump provides (orapproaches) a static flow rate, and the continuous infusion flow fromthe one or more infusion ports similarly provides (or approaches) astatic flow rate. In one example, the speed is varied in these regionsbetween an initial piston speed that nearly matches the piston speedwithin the intermediate segment and a greater terminating speed near theends of the top and bottom zones (e.g., at the end of the pistontravel).

The present inventors have recognized, among other things, that aproblem to be solved can include providing a continuous flow of infusionfluid to a vessel (e.g., for thrombus removal, contrast injection or thelike) with a single reciprocating piston. Multi-piston pumps, when thepistons are coordinated, are able to provide continuous flow. However,coordinating algorithms or mechanical linkages are needed to sync thepistons and provide a continuous flow of fluid. Additionally,multi-piston pumps have a large volume to accommodate the plurality ofcylinders, pistons and operating mechanisms.

Further still, an infusion system including the double action infusionprovides a single piston pump configured to provide a continuousuninterrupted flow of infusion fluid to a treatment site. In oneexample, the infusion system provided herein is used as a contrastinjector. In contrast to previous systems that use a single pistoncontaining a reservoir of contrast fluid within the cylinder, theinfusion system including the double action infusion pump is able tocontinuously deliver contrast fluid without refilling of the pumpcylinder. Instead, the contrast fluid is refilled in a reservoir (e.g.,fluid source) in communication with the double action infusion pump.

This overview is intended to provide an overview of subject matter ofthe present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the presentpatent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1 is a schematic view of one example of an infusion system.

FIG. 2 is an exploded view of one example of a double action infusionpump.

FIG. 3 is a cross sectional view of the double action infusion pump ofFIG. 2.

FIG. 4A is a schematic diagram showing a cylinder and piston of thedouble action infusion pump in two configurations.

FIG. 4B is a diagram showing the respective continuous flow rates of thedouble action infusion pump and a catheter in communication with thedouble action infusion pump.

FIG. 5 is a cross sectional view of one example of a catheter distalportion of a thrombectomy catheter.

FIG. 6 is a perspective view of one example of a catheter distal portionof a contrast injecting catheter.

FIG. 7 is a block diagram showing one example of a method of infusing afluid into a vessel.

DETAILED DESCRIPTION

FIG. 1 is a schematic view of one example of an infusion system 100. Theinfusion system 100 includes a pump operator 102 coupled with a doubleaction infusion pump 104. In the example shown in FIG. 1 the doubleaction infusion pump is a reciprocating pump having a piston movingwithin a cylinder. The infusion system 100, for instance the pumpoperator 102, includes a pump motor 106 configured to couple with thepiston of the double action infusion pump and accordingly reciprocatethe piston within the cylinder of the double action infusion pump. Aswill be described herein the double action infusion pump 104 provides acontinuous flow of fluid, for instance infusion fluid, to a cathetersuch as the catheter 110 shown in FIG. 1. The double action infusionpump 104 provides a continuous flow of fluid instance with reciprocationof the piston of the pump 104 by evacuating first and second pumpchambers within the cylinder separated by the movable piston. Thestructure and operation of the double action infusion pump 104 will bedescribed in further detail herein.

The output of the double action infusion pump 104 is in one example asubstantially continuous output of fluid (e.g., saline, lytics or thelike) provided to the catheter 110. In one example, the catheter 110includes one or more infusion ports 112 shown in FIG. 1. The continuousoutput of fluid (e.g., with some fluctuation at the top and bottom ofthe piston travel) from the double action infusion pump 104 iscorrespondingly delivered to the infusion ports 112. Accordingly, acontinuous flow of infusion fluid through the infusion ports 112 isprovided (e.g., with some fluctuation from a steady state flow rate).

Referring again to FIG. 1, in another example a fluid source 108 iscoupled with the catheter 110. For instance the fluid source 108 iscoupled with the double action infusion pump 104 and is deliveredthrough the double action infusion pump 104 to infusion ports 112. Theinfusion system 100 includes an effluent reservoir 114 configured toreceive an effluent provided by the catheter 110 (including in oneexample an entrained paniculate therein). In another example, forinstance where the catheter 110 is a contrast injecting catheter, theinfusion system 100 does not include the effluent reservoir or it isoptional. Optionally, the double action infusion pump 104 is a unitarypump module having a unitary pump body including for instance one ormore aspiration inlets and outlets configured to direct a flow ofaspirated fluid (effluent) from the catheter 110 through a moduleincluding the double action infusion pump as well as the aspirationinlet and outlet fittings. As shown in FIG. 1, the effluent reservoir114 is coupled with the double action infusion pump 104 and isaccordingly in communication with the catheter 110, for instance anaspiration lumen extending through the catheter 110.

FIG. 2 shows an exploded view of the double action infusion pump 104. Asshown, the double action infusion pump 104 includes a pump body 200, forinstance a unitary pump body formed from a single continuous piece ofmaterial. In the example, the cylinder 202 and the pump manifold 206 areformed as a single piece of material, for instance from a molded polymerresin. Where the double action infusion pump 104 is constructed with apolymer, in one example the cylinder 202 diameter and the correspondingpiston 204 diameter are enlarged to provide a high flow rate at lowpressures. Accordingly polymer fittings at the inlets and outlets, andthe structural integrity of the cylinder 202 and the piston 204 aremaintained while relatively high flow rates are realized. Optionally,the pump body 200 is machined from aluminum, steel or the like.Accordingly, the cylinder 202 and the corresponding inlets and outletshave increased structural integrity and the corresponding pump 104 isoperable at higher pressures and corresponding flow rates, or at higherpressures with a smaller cylinder 202 and piston 204.

As further shown in FIG. 2, the double action infusion pump 104 includesa piston 204. In one example the piston 204 is a multicomponent pistonincluding a series of seals configured to provide a sealing engagementbetween a piston disc 228 and the cylinder 202. The double actioninfusion pump 104 includes a series of inlets and outlets incommunication with first and second pump chambers formed by the movablepiston 204 and the cylinder 202. The contemporaneous evacuation andfilling of each of these pump chambers accordingly provides a continuousoutput of infusion fluid for instance through a manifold outlet fitting218 described in detail herein.

Referring again to FIG. 2, the piston 204 is shown in an explodedconfiguration. In the example shown the piston 204 includes a pistonshaft 224 having a piston fitting 226. The piston fitting 226 is sizedand shaped for engagement with a pump motor, such as the pump motor 106shown in FIG. 1. The piston shaft 224 extends to a piston seat 234 sizedand shaped to engage with a shaft seal 232 sized and shaped to maintaina fluid seal between the piston shaft 224 and at least the first pumpchamber provided between the piston 204 and the piston seat 234. Forinstance, in one example a shaft seal 232 is sandwiched between dualportions of the piston seat 234 to accordingly provide a tight sealagainst the piston shaft 224 and accordingly prevent the egress offluids from the cylinder 202. The piston shaft 224 is slidably receivedwithin the piston seat 234 and the shaft seal 232 and is coupled at anopposed end to the piston disc 228. In the example shown, the pistondisc 228 includes a piston seal 230 sized and shaped to engage insliding movement along the cylinder 202. The piston 204, including forinstance the piston disc 228 and the piston seal 230, bifurcates thecylinder 202 into first and second pump chambers.

Referring again to FIG. 2 the cylinder 202 is in communication with afirst fluid inlet 208 and a first fluid outlet 212 extending through thepump manifold 206. Similarly the second pump chamber (positionedrelatively below the piston 204) is in communication with a second fluidoutlet 214 and a second fluid inlet 210. The pump manifold 206 inanother example includes a manifold inlet fitting 216 and a manifoldoutlet fitting 218. The manifold inlet fitting 216 is optionally incommunication with the first fluid inlet 208 and the second fluid inlet210. As will be shown for instance in FIG. 3, the manifold inlet fitting216 is coupled with each of these fluid inlets 208, 210 to accordinglyprovide a source of fluid for each of the first and second pumpchambers. In a similar manner, the manifold outlet fitting 218 is incommunication with the first fluid outlet 212 and the second fluidoutlet 214 associated with the first and second pump chambers,respectively. The manifold outlet fitting 218 is accordingly configuredto couple with the catheter 110 shown in FIG. 1 and provide thecontinuous output of fluid flow from the pump 104 to the one or moreinfusion ports 112.

As further shown in FIG. 2 the double action infusion pump 104 includesa plurality of unidirectional valves provided in each of the inlets andoutlets to accordingly ensure a unidirectional flow of fluid form eachof the pump chambers. For instance, the first fluid inlet 208 includes aunidirectional inlet valve 220. In a similar manner, the second fluidinlet 210 includes a unidirectional inlet valve 220. The unidirectionalinlet valves 220 (e.g., check valves) allow the inflow of fluid forinstance into the cylinder 202 including the respective first and secondpump chambers.

In a similar manner, the first and second fluid outlets 212, 214correspondingly include unidirectional outlet valves 222. Theunidirectional outlet valves 222 cooperate to ensure evacuating fluidfrom the cylinders 202 is delivered out of the first fluid outlet andthe second fluid outlet 212, 214 and is not otherwise backflowed intothe cylinder 202, for instance during reciprocation of the piston 204while filling of either of the first and second piston chambers. Statedanother way, the unidirectional inlet valves 220 and the unidirectionaloutlet valves 222 cooperate to provide a one way flow of fluid from eachof the first and second pump chambers provided within the cylinder 202and separated by the piston 204. Accordingly, through reciprocation ofthe piston 204 a flow of fluid is continuously provided from either ofthe first and second fluid outlets 212. 214 throughout reciprocation ofthe piston 204.

Optionally, the unidirectional inlet and outlet valves 220, 222 arereversed. In the reversed configuration the double action infusion pump104 is operable as a vacuum pump. For instance, in one example, thedouble action infusion pump 104 or a second instance of the pump is usedas an aspiration pump to accordingly draw fluid (e.g., saline and bodyfluids with entrained particulate) to the effluent reservoir 114.Optionally, the pump in the vacuum configuration is coupled with theeffluent reservoir-114 and applies a negative pressure within thereservoir to accordingly apply suction (e.g., to an aspiration lumen orcatheter lumen of the catheter 110).

FIG. 3 shows another perspective view of the double action infusion pump104 previously shown in FIG. 2. In this view the interior of theinfusion pump is provided in broken lines. For instance the cylinder 202is shown divided by the piston 204 received therein. As shown in FIG. 3,the cylinder 202 is accordingly divided into a first pump chamber 300and a second pump chamber 302. The first pump chamber 300 is incommunication with the first and second fluid inlet and outlet 208, 212.In a similar manner, the second pump chamber 302 is in communicationwith the second fluid inlet and second fluid outlet 210, 214. Aspreviously described each of the first fluid inlet and second fluidinlet 208, 210 are in one example in communication with a manifold inletfitting 216. For instance, an inlet interconnect 306 formed within thepump manifold 206 provides communication between each of the first fluidinlet 208 and the second fluid inlet 210. In one example the manifoldinlet fitting 216 is in communication with the fluid source 108previously shown in FIG. 1.

In a similar manner to the first and second fluid inlets 208, 210, thefirst and second fluid outlets 212, 214 are in communication optionallywith one another by way of an outlet interconnect 304. As shown in FIG.3 each of the outlets 212, 214 are in communication by way of theinterconnect 304 and accordingly provide their outputs through themanifold outlet fitting 218, for instance to the catheter 110 as shownin FIG. 1. In another example, each of the first and second fluid inlets208, 210 and the first and second fluid outlets 212, 214 arerespectively interconnected directly with a catheter such as thecatheter 110. For instance the pump manifold 206 houses each of theinlets and outlets and accordingly allows for separate communication ofeach of the inlets and outlets with the corresponding catheter 110 orfluid source 108.

As further shown in FIG. 3 and as previously described herein, in oneexample the pump body 200 is a unitary pump body combining one or morefeatures into a modular component assembly configured for installationwithin the pump operator 102 including the pump motor 106 shown inFIG. 1. That is to say, the double action infusion pump 104 includingfor instance a unitary pump body 200 is loaded as a single module intopump operator 102 and coupled with the catheter 110 as well as aneffluent reservoir 114.

In one example, the pump operator 102 includes an aspiration pump suchas a roller pump, a diaphragm pump or the like interposed between theeffluent reservoir 114 and the double action infusion pump 104. Theeffluent pump provides a source of aspiration (e.g., a vacuum) withinthe catheter 110 and accordingly moves an effluent fluid (e.g., areturning fluid from the catheter 110 including for instance thrombus orplaque particulate therein) through the unitary pump body 200 andthereafter into the effluent reservoir 114. As shown in FIG. 3 in oneexample the pump body 200 in one example includes an aspiration inlet308 and an aspiration outlet 310 formed in the pump body 200. As furthershown in the figure an aspiration passage 312 provides communicationbetween each of the aspiration inlet and the aspiration outlet 310.Accordingly, the aspiration inlet and outlet 308, 310 cooperate toprovide an effluent passage through the pump body 200. The modular pumpbody 200 installed within the pump operator 102 accordingly facilitatescommunication from the fluid source 108 to the catheter 110 and from thecatheter 110 to the effluent reservoir 114.

Referring now to FIG. 4A the cylinder 202 previously shown in FIGS. 2and 3 is shown in dual schematic representations with the piston 204 inan upward position in the leftmost view and the piston 204 in a lowerposition in the rightmost view. In both views the cylinder 202 includesfirst and second pump chambers 300, 302 formed by the piston 204 and thecylinder 202. As shown between the two views the first and second pumpchambers 300, 302 have variable volumes according to the movements ofthe piston 204. The cylinder 202 includes first and second fluid inlets208, 210 and first and second fluid outlets 212, 214. Each of the pairsof fluid inlets and outlets are associated with one of the first andsecond pump chambers 300, 302 as shown in each of the schematic views.As further shown in the schematic views each of the inlets and outletsinclude corresponding unidirectional inlet valves 220 and unidirectionaloutlet valves 222 such as check valves. Check valves facilitate in theexample of the unidirectional inlet valve 220 filling of each of therespective first and second pump chambers 300, 302. In contrast theunidirectional outlet valves 222 associated with the first and secondfluid outlets 212, 214 facilitate the evacuation of each of the firstand second pump chambers 300, 302 for instance as the fluid within eachof the chambers is pressurized during reciprocation of the piston 204.

In operation the piston 204 is reciprocated within the cylinder 202 toaccordingly fill and evacuate each of the first and second pump chambers300, 302. For instance, in the leftmost view the piston 204 is shown inan ascending configuration. In this configuration fluid within the firstpump chamber 300 is pressurized and delivered through the first fluidoutlet 212. In a converse manner, as the piston 204 ascends the secondpump chamber 302 is filled for instance by a flow of fluid through theunidirectional inlet valve 220 of the second fluid inlet 210.Accordingly, as one of the first or second pump chambers 300, 302 isfilling the opposed chamber is evacuating. The rightmost view of FIG. 4Ashows the piston 204 in a descending configuration. In thisconfiguration the first pump chamber 300 is filling for instance throughthe first fluid inlet 208 while the second pump chamber 302 isevacuating for instance by pushing pressurized fluid through the secondfluid outlet 214.

According to the views shown in FIG. 4A a near continuous flow of fluidfrom the double action infusion pump 104 is provided, for instance asone of the first or second pump chambers 300, 302 is filling and theother is evacuating. Because one of the first and second pump chambersis evacuating during ascent or descent of the piston 204 a substantiallycontinuous output is provided from the double action infusion pump(excepting a momentary pause at the top and bottom of the piston 204travel). Similarly while one of the chambers is evacuating the other ofthe two chambers 300, 302 is filling to accordingly facilitate thecontinued delivery of fluid upon reciprocation of the piston 204 in theopposed direction.

Referring again to FIG. 4A the piston 204 is shown moving throughvarious segments of the cylinder 202. In one example, an intermediatesegment 404 spans a portion of the length of the cylinder 202 betweentop and bottom zones 406, 408. The intermediate segment 404 assumes themajority of the length of the cylinder 202 in an example. In anotherexample, the intermediate segment 404 forms some portion of the cylinder202 less than or equal to half of the cylinder length. As shown in FIG.4A, the intermediate segment 404 spans between positions near the inletsand outlets 208, 210, 212, 214 but is spaced from the inlets and outletsrelative to the top and bottom zones 406, 408 that are more closelypositioned relative to the respective inlets and outlets.

As previously described the piston 204 is reciprocated. Stated anotherway, the piston 204 is moved in a first direction such as an ascendingdirection (the left view of FIG. 4A) to deliver pressurized fluid fromthe first pump chamber 300 for instance to a catheter such as thecatheter 110 as shown in FIG. 1. Once the piston 204 is moved into anupward configuration for instance toward the end of the top zone 406 thepiston 204 is reversed and moved in a second direction such as thedescending configuration shown in the right view of FIG. 4A andeventually travels through the bottom zone 408. Accordingly, fluidwithin the second pump chamber 302 is pressurized and delivered throughthe second fluid outlet 214.

As the piston 204 reaches the top and bottom of its travel the pistonexperiences a momentary pause before it begins its reversed movement inthe opposed direction. In one example, the double action infusion pump104 described herein is configured to accelerate the movement of thepiston 204 within each of the top and bottom zones 406, 408 relative tothe intermediate segment 404 to attenuate the pause in the piston 204and the according pause in delivery of fluid for instance from the firstand second fluid outlets 212, 214. Stated another way, by acceleratingthe piston 204 in the top and bottom zones 406, 408 to a second speedgreater relative to a first speed within the intermediate segment 404the output from the first and second fluid outlets 212, 214 (e.g., aflow rate) is increased within the top and bottom zones 406, 408.Accordingly, a greater volume of fluid output from the double actioninfusion pump 104 is provided within the zones 406, 408 that allows forthe maintenance of a substantially continuous output from the doubleaction infusion pump 104 with only moderate variation in the overalloutput. The fluid flow delivered by catheter 110 for instance a contrastinjecting catheter, thrombectomy catheter and the like is correspondingsubstantially continuous (e.g., having minor fluctuations) laggingbehind the corresponding fluctuations in the substantially continuousoutput of the double action infusion pump 104.

In one example, the piston 204 within the intermediate segment 404 movesat a first piston speed, for instance a piston speed of around 0.01inches to around 2 inches per second. At an interface between the topand bottom zones 406, 408 with the intermediate segment 404 the piston204 accelerates or changes its speed to a second higher speed. Theoutput of the double action infusion pump 104 correspondingly increaseswith the increased speed of the piston 204.

Optionally, as the piston 204 continues to ascend or descend within therespective top and bottom zones 406, 408 the speed within these zones isfurther increased for instance from an initial piston speed at theinterface to a terminating piston speed near the end of each of thezones 406, 408. Accordingly, the fluid flow rate of the double actioninfusion pump at least within the top and bottom zones 406, 408continues to rise as the piston 204 approaches the ends of therespective zones. In a similar manner, upon reaching the end of each ofthe zones the piston 204 reverses direction and begins moving againthrough the top or bottom zones 406, 408 toward the intermediate segment404. Optionally the piston 204, while departing from the end of each ofthe top and bottom zones 406, 408, accelerates within the top and bottomzones 406, 408 to accordingly increase its output and maintain a nearsteady state constant volume of flow for the double action infusion pump104. In still another example, the speed of the piston 204 on anupstroke (e.g., the leftmost view of FIG. 4A) is higher in one or moreof the intermediate segment 204 or the top and bottom zones 406, 408relative to the corresponding speeds of the downstroke to account forthe change in volume caused by the piston shaft 224 (as shown in FIG.2). Accordingly, by varying speed between the upstroke and downstroke asubstantially continuous output of fluid from the pump 104 and flow offluid at the catheter 110 are achieved.

Referring to FIG. 4B, the output of the pump 104 for instance a value Qcorresponding to the flow rate of the double action infusion pump 104 isplotted relative to a flow rate (Q of the infusion ports) correspondingto the output of a catheter, such as the catheter 110 shown in FIG. 1.As shown in the first plot corresponding to the flow rate of the pump104 relative to time the flow rate of the pump is relatively constantthrough a time period corresponding to t_(j) which is the time thepiston 204 moves within the intermediate segment 404. As the pistonmoves into the top zone or bottom zone 406, 408 (t_(TZ), t_(BZ).respectively) and accordingly increases its speed the output of the pumpaccordingly rises (e.g., during a time of approach, time t_(a)). Uponreaching the end of either the top or bottom zones 406, 408 the pistonpauses and then begins its descent or ascent (departs) from the top orbottom zones 406,408, respectively. As further shown in the first plotin FIG. 4B, the flow rate immediately rises toward the intermediatesegment flow rate within the segment t_(d) (e.g., during a time ofdeparture from the end of the top or bottoms zones 406, 408). Byaccelerating the piston 204 for instance raising its speed relative to afirst speed within the intermediate segment 404 to a second speed ineach of the top and bottom zones 406, 408 the overall output of thedouble action infusion pump 104 remains substantially constant, forinstance rising and falling relative to a steady state output. Cessationof flow, for instance at the ends of the piston travel 204 is attenuatedby way of accelerating the piston 204 within the top and bottom zones406, 408.

Referring again to FIG. 4B the output of the one or more infusion ports112 (the flow rate Q) is shown plotted relative to the output of thepump in the upper view. As shown the output of the infusion ports 112lags slightly behind the output of the pump according to drag within thecatheter 110 and the catheter length from the double action infusionpump 104 to the ports 112. As shown, with the substantial continuity ofthe pump output shown in the first view the corresponding fluid flow atthe infusion ports 112 is substantially constant with only slightfluctuation around the stead state flow rate within a time period(T_(QF)). In the remainder of the plot of the flow rate the flow rate atthe infusion ports 112 is substantially constant (T_(QC)).

Accordingly as shown in FIGS. 4A and 4B, by alternating filling andevacuating of each of the first and second pump chambers 300, 302 whileat the same time varying the speed of the piston 204 a continuous outputof fluid is provided by the double action infusion pump 104 (with slightfluctuations in the flow rate for instance corresponding to the top andbottom zones 406, 408) and a continuous flow of fluid at the one or moreinfusion ports 112 of the is provided (with some attenuated fluctuationscorresponding to the changes in speed and the reversal of movement tothe piston 204 as shown in FIG. 4A). That is to say, by changing thespeed of the piston 204 the output of the double action infusion pump104 described herein is made substantially continuous. Correspondingly,the output of the catheter 112 for instance a flow of fluid from theinfusion ports 112 is also substantially continuous. Stated another way,the substantially continuous output of the double action infusion pump104 and the catheter 110 have slight variations relative to a steadystate flow rate but are otherwise continuous during the reciprocation ofthe piston 204 within the cylinder 202.

Referring now to FIG. 5 one example of a catheter, such as a distalportion 500 of the catheter 110 shown in FIG. 1 is provided. In thisexample the catheter 110 includes an emanator 504 positioned within thedistal portion 500 of the catheter. The emanator 504 includes aplurality of infusion ports 508 arranged around a ring like structure ofthe emanator 504. An infusion tube such as the infusion tube 502 shownin FIG. 5 is in communication with the emanator 504 and delivers apressurized fluid such as saline, lytics or the like to the infusionports 508. Accordingly, one or more fluid jets 506 are formed within thecatheter 110 and directed proximally for instance back toward the pumpoperator 102 shown in FIG. 1. The fluid jets 506 are configured toprovide a proximal flow of fluid within the catheter distal portion 500.As shown in FIG. 5, the proximal flow generates a recirculating flow 514of the fluid. For instance the distal portion of the catheter 500includes an outflow orifice 510 and an inflow orifice 512 incommunication with the flow of the fluid jets 506. The pressurized fluidjets 506 create an exterior flow of fluid through the outflow orifice510 that allows the infused fluid to entrain particulate, such asthrombus or the like, therein and return the fluid with the entrainedparticulate through the outflow orifice 512 for maceration of theparticulate and delivery of the particulate along the catheter 110, forinstance to an effluent reservoir such as the reservoir 114 shown inFIG. 1.

In one example, the continuous output of the double action infusion pump104 is provided by way of the infusion tube 502 to the emanator 504 toaccordingly generate the fluid jets 506 and the correspondingrecirculating flow 514. As previously described, the continuous outputof the double action infusion pump 104 results in a correspondingcontinuous flow of fluid through the emanator 504 by way of the infusiontube 502. Accordingly, the recirculating flow 514 and the fluid jets 506are substantially continuous and thereby able to generate a continuousrecirculating flow 514 to ensure the reliable hydrodynamic-based removalof thrombus and particulate maceration, and further ensure continuousdelivery of the entrained particulate to the effluent reservoir 114provided in FIG. 1.

In another example, the distal portion 500 of the catheter includesdirect spray infusion orifices in contrast to the recirculating flowprovided with the inflow and outflow orifices 512, 510. Stated anotherway, the infusion tube 502 extends to the distal portion 500 andcommunicates with one or more infusion ports (e.g., the infusion ports112 shown in FIG. 1). Alternatively, the infusion tube 502 communicateswith an emanator like the ring type emanator shown in FIG. 5. Theemanator includes peripheral infusion orifices directed through thecatheter sidewall and to the exterior of the catheter. Accordingly, theemanator delivers streams or sprays of infusion fluid directly to thevasculature (e.g., thrombus within the vasculature).

FIG. 6 shows another example of a distal portion 600 of a catheter, forinstance in a contrast injecting catheter. As shown in the example, thedistal portion 600 of the catheter includes an optional dilating balloon602 sized and shaped to inflate within a vessel and accordingly occludethe vessel to facilitate the delivery of contrast fluid to a location ofinterest. The distal portion of the catheter 600 includes at least oneinfusion port 604, such as a contrast injecting port sized and shaped toprovide a flow of contrast fluid distal to the dilating balloon 602. Forinstance, as previously described herein the infusion port 604 is incommunication with the double action infusion pump 104. The continuousoutput of the double action infusion pump 104 is delivered along thecatheter to the contrast infusing port 604 to accordingly deliver acontrast fluid in a continuous manner (e.g., with a continuous flow offluid) to a location to be observed. Optionally, the infusion port isprovided as a relatively large orifice, for instance within a deliverysheath or relatively large diameter catheter to accordingly facilitatedelivery of the relatively viscous contrast fluid. In another example,the distal portion 600 of the catheter includes an infusion port 604without a dilating balloon 602.

With the double action infusion pump 104 described herein, withreciprocation of a single piston such as the piston 204 shown in FIGS. 2and 3 the pump 104 is able to generate, respectively, a substantiallycontinuous output of fluid and substantially continuous flow of fluidfrom the pump and a catheter 110 coupled with the pump. Stated anotherway, with only minor fluctuations of an otherwise constant or staticflow rate the double action infusion pump 104 is able by way of a singlepiston and cylinder combination 204,202 to provide a continuous flow offluid at one or more infusion ports 112 associated with the catheter 110(e.g., the infusion ports 508 or the infusion port 604).

FIG. 7 shows one example of a method 700 of infusing a fluid into avessel. In describing the method 700 reference is made to one or morecomponents, features, steps and the like described herein. Whereconvenient reference is made to the components, features and the likewith reference numerals. The reference numerals provided are exemplaryand are not exclusive, for instance the features, components and thelike described in the method 700 include but are not limited to thecorresponding numbered elements, other corresponding features describedherein (both numbered and unnumbered) as well as their equivalents.

At 702, a catheter such as a catheter 110 shown in FIG. 1 having acatheter distal (e.g., either of the catheter distal portions 500, 600shown in FIGS. 5 and 6) is positioned at a treatment location within thevessel. The catheter distal portion (500 or 600) includes one or moreinfusion ports (e.g., the infusion ports 508 and 604). As shown in FIGS.5 and 6 in one example the catheter 110 shown in FIG. 1 includes athrombectomy catheter configured to provided a recirculating flow offluid 514 through an outflow orifice 510 and an inflow orifice 512 asshown in FIG. 5. The catheter 110 includes in another example, acontrast injecting catheter including for instance the catheter distalportion 600 shown in FIG. 6. In one example the contrast injectingcatheter includes a dilating balloon 602 as well as an infusion port 604sized and shaped to deliver a contrast fluid distally relative to thedilated balloon 602.

At 704, the method includes continuously outputting a fluid from adouble action infusion pump 104 in communication with a fluid source108, such as a source of contrast fluid, infusion fluid (saline,lytics)) or the like. Continuously outputting the fluid includes movingthe reciprocating piston 204 in a first direction within a cylinder suchas the cylinder 202 and moving the reciprocating piston in a secondopposed direction within the cylinder 202. In one example, moving thereciprocating piston includes filling a first pump chamber 300 with thefluid within the cylinder while at the same time evacuating the fluidfor instance another volume of the fluid from a second pump chamber 302also within the cylinder 202 (see the rightmost view of FIG. 4A).Accordingly, while the first pump chamber 300 is filling the second pumpchamber 302 with the piston 204 moving in the first direction isaccordingly evacuating to provide a first portion of flow to thecatheter 110 as shown in FIG. 1.

At 708, moving the reciprocating piston in a second direction such as anopposed direction (including for instance the leftmost view of FIG. 4A)includes filling the second pump chamber 302 with the fluid for instancethe fluid provided by the fluid source 108 shown in FIG. 1. At the sametime the first pump chamber 300 is evacuated, for instance by the piston204 collapsing the first pump chamber 300 and accordingly deliveringfluid from one of the two fluid outlets 212, 222 as shown in FIG. 4A.Accordingly, and in a similar manner to reciprocation of the piston inthe first direction, reciprocation of the piston 204 in the seconddirection correspondingly fills the second pump chamber as the firstpump chamber is evacuated. With reciprocation of the piston in the firstand second directions a substantially continuous output of fluid isprovided.

At 710 the method 700 further includes varying the speed of thereciprocating piston 204 in the first and second directions to providethe continuous output of the fluid between the first and second pumpchambers 300, 302. That is to say, in one example the piston 404 ismoved along an intermediate segment 404 of the cylinder 202 at a firstpiston speed, for instance a piston speed of between about 0.01 inchesto 2 inches per second. As the piston 204 enters the top and bottomzones 406, 408 the piston is accelerated and its speed is increased to asecond piston speed greater than the first piston speed to accordinglyincrease the flow rate of the double action infusion pump 104 within thecorresponding top and bottom zones 406, 408. As previously describedherein, by increasing the flow rate of the double action fusion pump 104within each of the top and bottom zones 406, 408 (by raising the speedof the piston 204 within these zones) the output of fluid from thedouble action infusion pump 104 is continuous. That is to say, whilethere is some fluctuation near the top and bottom zones 406, 408 in theoverall output of fluid, the output is substantially continuous as thepiston 204 is accelerated toward the top and bottom zones 406, 408 (anoptionally while departing from the top and bottom zones 406, 408) toincrease the overall flow rate and thereby offset any decrease in flowrate otherwise provided by the pause of the piston 204 at the top andbottom of its movement.

At 712 fluid is continuously delivered through the one or more infusionpoints 112 of the catheter 110 based on the continuous output from thedouble action infusion pump 104. Referring to FIG. 4B, as shown with theflow rate of the pump 104 shown in the first plot adjusted according tothe variations in speed of the piston 204 the corresponding output orfluid flow from the catheter infusion ports 112 is shown in the bottomplot. With the change in speed within the top and bottom zones 406, 408the output of the double action infusion pump 104 increases in thesezones to substantially realize an overall continuous output of fluidthat offsets the decrease in output with the pause of reciprocation ofthe piston 204. Accordingly, the output of the catheter 110 for instancewith the infusion ports 112 is substantially continuous and anyfluctuations in the output from the double action infusion pump 104 areattenuated by drag in the catheter and connecting tubing and dispersionof the fluid within the catheter 110 to accordingly provide asubstantially continuous flow rate with only minor variations (laggingthose variations in the pump output).

Several options for the method 700 follow. In one example, filling ofthe first and second pump chambers 300, 302 with the fluid includesdelivering fluid through respective first and second fluid inlets 208,210 to the first and second pump chambers 300, 302 respectively. Thefirst and second fluid inlets each include a unidirectional valve 220 aspreviously described herein. In a contrast, evacuating the fluid fromthe first and second pump chambers 300, 302 includes delivering fluidthrough the outlets 212, 214. In one example the first and second fluidoutlets each include unidirectional outlet valves 222 as previouslyshown in FIGS. 2 and 4A.

In another example, varying the speed of the reciprocating piston 204includes varying the speed between an intermediate segment 404 of thecylinder 202 and within top and bottom zones 406, 408 of the cylinder202. Varying of the speed includes in one example moving thereciprocating piston 204 at a first piston speed along the intermediatesegment 404 and moving the reciprocating piston 204 at a second pistonspeed greater than the first piston speed within the top and bottomzones 406, 408. Optionally, moving the reciprocating piston 204 at thesecond speed, for instance within the top and bottom zones 406, 408,includes moving the reciprocating piston 204 near an interface betweenthe intermediate segment 404 and each of the top and bottom zones 406,408 at an initial piston greater than the first piston speed within theintermediate segment 404. Additionally moving the reciprocating pistonnear ends of the top and bottom zones 406, 408 (adjacent to the end ofthe travel of the piston 204 in each of the reciprocating directions)includes moving at a terminating piston speed greater than the initialpiston speed within the top and bottom zones 406, 408. Stated anotherway, the piston 204 optionally accelerates (or assumes 2 or more speeds)from between the interface between the top and bottom zones 406, 408 tothe end of it travel within each of the top and bottom zones 406, 408.

In another example continuously delivering the fluid through the one ormore infusion ports 112 includes continuously delivering a contrastfluid through one or more infusion ports such as the infusion port 604shown in FIG. 6 with the contrast injecting catheter distal portion 600shown in FIG. 6. In another example, continuously delivering the fluidthrough the one or more infusion ports includes generating therecirculating fluid loop such as the fluid loop 514 shown in FIG. 5.Generating the recirculating fluid loop 514 includes in one examplecontinuously delivering the fluid through a fluid jet emanator 504within a catheter lumen of the catheter such as the catheter distalportion 500 shown in FIG. 5. A portion of the continuously deliveredfluid is provided through an outflow orifice 510 of the catheter incommunication with the catheter lumen. The portion of the fluiddelivered through the outflow orifice is returned through an infloworifice 512 (with entrained paniculate therein). The inflow orificecommunicates with the catheter lumen and the plurality of fluid jets 506provided by the emanator 504.

In still another example, the method 700 further includes filling afluid source such as the fluid source 108 while continuously outputtingthe fluid from the double action infusion pump 104 at the same time.That is to say, the double action infusion pump 104 may be operatedcontinuously without needing to reload the cylinder or other feature ofa pump to accordingly provide a renewed flow of fluid. Instead, thefluid source 108 provides an open ended supply of fluid to the doubleaction infusion pump 104. Accordingly, with continued refilling of thefluid source 108 as needed the double action infusion pump 104 is ableto continuously output a flow of fluid from the pump 104 and accordinglyprovide a continuous flow of fluid from the catheter 110, for instancechronically or near chronically positioned within a patient.

VARIOUS NOTES & EXAMPLES

Example 1 can include subject matter such as an infusion system that caninclude a fluid source; a double action infusion pump in communicationwith the fluid source, the double action infusion pump including: acylinder, a reciprocating piston received within the cylinder, thereciprocating piston separating a first pump chamber from a second pumpchamber of the cylinder, each of the first and second pump chambershaving a variable volume, a reciprocating motor coupled with thereciprocating piston, and the first and second pump chambers alternatebetween filling and evacuating conditions with reciprocation of thereciprocating piston through operation of the reciprocating motor, andthe speed of reciprocation is varied to provide a continuous output offluid between the first and second pump chambers; and a catheter coupledwith the double action infusion pump, the catheter including one or moreinfusion ports near a catheter distal portion, and the one or moreinfusion ports receive and expel the continuous output of fluid from thedouble action infusion pump.

Example 2 can include, or can optionally be combined with the subjectmatter of Example 1, to optionally include wherein the fluid source iscoupled with the first and second pump chambers with first and secondfluid inlets, respectively, and the catheter is coupled with the firstand second pump chambers with first and second fluid outlets,respectively.

Example 3 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 or 2 to optionallyinclude wherein the first and second fluid inlets include unidirectionalvalves therein configured to allow inflow into the respective first andsecond pump chambers, and the first and second fluid outlets includeunidirectional valves therein configured to allow outflow from therespective first and second pump chambers.

Example 4 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 3 to optionallyinclude wherein the piston is reciprocated along an intermediate segmentof the cylinder and through top and bottom zones, and along theintermediate segment of the cylinder the reciprocating motor moves thepiston at a first piston speed, and within the top and bottom zones thereciprocating motor moves the piston at a second piston speed greaterthan the first piston speed.

Example 5 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-4 to optionally includewherein the reciprocating motor moves the piston at the first and secondpiston speeds to provide the continuous output of fluid received andexpelled by the infusion ports.

Example 6 can include, or can optionally be combined with the subjectmatter of Examples 1-5 to optionally include wherein the second pistonspeed includes a plurality of speeds including an initial piston speedand a terminating piston speed, and an initial piston speed near aninterface of each of the top and bottom zones within the intermediatesegment is greater than the first piston speed in the intermediatesegment, and a terminating piston speed near ends of the top and bottomzones is greater than the initial piston speed.

Example 7 can include, or can optionally be combined with the subjectmatter of Examples 1-6 to optionally include wherein the catheterincludes a contrast infusion catheter, and the continuous flow of fluidfrom the catheter is a continuous flow of contrast fluid.

Example 8 can include, or can optionally be combined with the subjectmatter of Examples 1-7 to optionally include wherein the catheterincludes a fluid jet emanator within a catheter lumen, and the one ormore infusion ports include at least one outflow orifice in a catheterside wall in communication with the fluid jet emanator, and the catheterincludes at least one inflow orifice in communication with the fluid jetemanator, and wherein the continuous flow of fluid is directed throughthe fluid jet emanator according to the continuous output of fluidbetween the first and second pump chambers, the continuous flow of fluidfrom the fluid jet emanator configured to generate a recirculating fluidloop through the inflow and outflow orifices between a catheter lumenand a catheter exterior.

Example 9 can include, or can optionally be combined with the subjectmatter of Examples 1-8 to optionally include an infusion systemcomprising a fluid source; a catheter including one or more infusionports near a catheter distal portion; and a double action infusion pumpin communication with the fluid source and the catheter, the doubleaction infusion pump including: a cylinder, a reciprocating pistonreceived within the cylinder, the reciprocating piston separating afirst pump chamber from a second pump chamber of the cylinder, a firstfluid inlet and first fluid outlet coupled with the first pump chamber,a second fluid inlet and second fluid outlet coupled with the secondpump chamber, each of the first fluid inlet and outlet and the secondfluid inlet and outlet includes a unidirectional valve therein, andwherein the first and second fluid inlets are in communication with thefluid source, and the first and second fluid outlets are incommunication with the one or more infusion portions of the catheter.

Example 10 can include, or can optionally be combined with the subjectmatter of Examples 1-9 to optionally include a unitary pump body, andeach of the cylinder, the first fluid inlet and outlet, and the secondfluid inlet and outlet are formed from the unitary pump body, and theunitary pump body is configured for modular loading within a pumpoperator including a reciprocating motor, and the reciprocating motor isconfigured for engagement with the piston.

Example 11 can include, or can optionally be combined with the subjectmatter of Examples 1-10 to optionally include wherein the unitary pumpbody includes an aspiration interface, the aspiration interfaceincluding: an aspiration inlet configured for coupling with a catheterlumen of the catheter, and an aspiration outlet in communication withthe aspiration inlet, the aspiration outlet configured for coupling withan effluent reservoir.

Example 12 can include, or can optionally be combined with the subjectmatter of Examples 1-11 to optionally include wherein the double actioninfusion pump is operated in an intermediate configuration and a deadcenter configuration, in the intermediate configuration the piston ismoved at a first piston speed within an intermediate segment of thecylinder between top and bottom zones of the cylinder, and in the topand bottom configuration the piston is moved at a second piston speedwithin the top and bottom zones.

Example 13 can include, or can optionally be combined with the subjectmatter of Examples 1-12 to optionally include wherein operation of thedouble action infusion pump in the intermediate and the top and bottomconfigurations is configured to generate a continuous output of fluidbetween the first and second pump chambers and a correspondingcontinuous flow of fluid from the catheter.

Example 14 can include, or can optionally be combined with the subjectmatter of Examples 1-13 to optionally include wherein the catheterincludes a contrast infusion catheter, and the continuous flow of fluidfrom the catheter is a continuous flow of contrast fluid.

Example 15 can include, or can optionally be combined with the subjectmatter of Examples 1-14 to optionally include a method of infusing afluid into a vessel comprising: positioning a catheter distal portion ata treatment location, the catheter distal portion including one or moreinfusion ports; continuously outputting a fluid from a double actioninfusion pump in communication with a fluid source, continuouslyoutputting including: moving a reciprocating piston in a first directionwithin a cylinder including filling a first pump chamber within thecylinder with the fluid, and at the same time evacuating the fluid froma second pump chamber within the cylinder, moving the reciprocatingpiston in a second direction including filling the second pump chamberwith the fluid, and at the same time evacuating the fluid from the firstpump chamber, and varying the speed of the reciprocating piston in thefirst and second directions to provide the continuous output of thefluid between the first and second pump chambers; and continuouslydelivering the fluid through the one or more infusion ports based on thecontinuous output from the double action infusion pump.

Example 16 can include, or can optionally be combined with the subjectmatter of Examples 1-15 to optionally include wherein filling the firstand second pump chambers with the fluid includes delivering fluidthrough respective first and second fluid inlets to the first and secondpump chambers, the first and second fluid inlets each including aunidirectional valve.

Example 17 can include, or can optionally be combined with the subjectmatter of Examples 1-16 to optionally include wherein evacuating thefluid from the first and second pump chambers includes delivering fluidthrough respective first and second fluid outlets from the first andsecond pump chambers, the first and second fluid outlets each includinga unidirectional valve.

Example 18 can include, or can optionally be combined with the subjectmatter of Examples 1-17 to optionally include wherein varying the speedof the reciprocating piston includes varying the speed between anintermediate segment of the cylinder and within top and bottom zones ofthe cylinder including: moving the reciprocating piston at a firstpiston speed along the intermediate segment, and moving thereciprocating piston at a second piston speed greater than the firstpiston speed within the top and bottom zones.

Example 19 can include, or can optionally be combined with the subjectmatter of Examples 1-18 to optionally include wherein moving thereciprocating piston at the second piston speed includes: moving thereciprocating piston near an interface between the intermediate segmentand each of the top and bottom zones includes moving at an initialpiston speed greater than the first piston speed in the intermediatesegment, and moving the reciprocating piston near ends of the top andbottom zones includes moving at a terminating piston speed greater thanthe initial piston speed.

Example 20 can include, or can optionally be combined with the subjectmatter of Examples 1-19 to optionally include wherein continuouslydelivering the fluid through the one or more infusion ports includescontinuously delivering a contrast fluid through the one or moreinfusion ports.

Example 21 can include, or can optionally be combined with the subjectmatter of Examples 1-20 to optionally include wherein continuouslydelivering the fluid through the one or more infusion ports includesgenerating a recirculating fluid loop including: continuously deliveringthe fluid through a fluid jet emanator within a catheter lumen of thecatheter, delivering a portion of the continuously delivered fluidthrough an outflow orifice of the catheter in communication with thecatheter lumen, returning the portion of the continuously deliveredfluid through an inflow orifice of the catheter in communication withthe catheter lumen, and entraining paniculate within the returnedportion of the continuously delivered fluid.

Example 22 can include, or can optionally be combined with the subjectmatter of Examples 1-21 to optionally include filling a fluid sourcewhile continuously outputting the fluid from the double action infusionpump.

Each of these non-limiting examples can stand on its own, or can becombined in any permutation or combination with any one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

Method examples described herein can be machine or computer-implementedat least in part. Some examples can include a computer-readable mediumor machine-machine-readable medium encoded with instructions operable toconfigure an electronic device to perform methods as described in theabove examples. An implementation of such methods can include code, suchas microcode, assembly language code, a higher-higher-level languagecode, or the like. Such code can include computer readable instructionsfor performing various methods. The code may form portions of computerprogram products. Further, in an example, the code can be tangiblystored on one or more volatile, non-transitory, or non-volatile tangiblecomputer-readable media, such as during execution or at other times.Examples of these tangible computer-readable media can include, but arenot limited to, hard disks, removable magnetic disks, removable opticaldisks (e.g., compact disks and digital video disks), magnetic cassettes,memory cards or sticks, random access memories (RAMs), read onlymemories (ROMs), and the like.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

The claimed invention is:
 1. A method of infusing a fluid into a bodylumen, the method comprising: positioning an infusion catheter adjacenta target site within the body lumen; continuously outputting the fluidfrom an infusion pump into the infusion catheter, the infusion pumpincluding a single chamber having a first end region and a second endregion opposite the first end region, wherein the single chamber extendscontinuously between the first end region and the second end region,wherein the first end region includes a first fluid inlet and the secondend region includes a second fluid inlet, and wherein continuouslyoutputting the fluid includes: moving a single piston within the singlechamber between the first end region and the second end region such thatthe piston passes through the first end region of the chamber at a firstspeed, the second end region of the chamber at a second speed, and atransition section of the chamber at a third speed, wherein thetransition section is positioned between the first end region of thechamber and the second end region of the chamber, and wherein the first,the second or both the first and second speeds are greater than thethird speed; and varying the first speed, the second speed and/or thethird speed to continuously output the fluid out of the pump.
 2. Themethod of claim 1, wherein the piston has a first acceleration from thethird speed to the first speed, and wherein the piston has a secondacceleration from the third speed to the second speed.
 3. The method ofclaim 2, wherein the first acceleration and the second acceleration areconfigured to provide the continuous output of fluid out of the pump. 4.The method of claim 1, wherein the first, second and third piston speedscorrespond to a first output of fluid out of the pump, a second outputof fluid out of the pump and a third output of fluid out of the pump,and wherein the first output, the second output or both the first andsecond outputs are greater than the third output.
 5. The method of claim1, wherein the first, second and third speeds are variable, and whereinthe piston adjusts the first, second and/or third speeds in response tooutputting the fluid out of the pump.
 6. The method of claim 1, whereinmoving the piston through the first section further comprises fillingthe first section with fluid while simultaneously evacuating fluid fromthe second section.
 7. The method of claim 1, wherein moving the pistonthrough the second section further comprises filling the second sectionwith fluid while simultaneously evacuating fluid from the first section.8. The method of claim 1, wherein the piston separates the first endregion from the second end region.
 9. The method of claim 1, wherein thetransition section spans a distance between the at least one inletcoupled to the first end region and the at least one inlet coupled tothe second end region.
 10. The method of claim 9, wherein the at leastone inlet coupled to the first end region and the at least one inletcoupled to the second end region includes at least one unidirectionalvalve.
 11. The method of claim 1, wherein the distal end region of theinfusion catheter includes one or more fluid infusion ports, and whereinthe continuous output of fluid is directed through the one or moreinfusion ports.
 12. A method of infusing fluid into a body lumen, themethod comprising: positioning an infusion catheter adjacent a targetsite within the body lumen, the infusion catheter including a distal endregion and a proximal end region, the proximal end region coupled to aninfusion pump, wherein the infusion pump includes: a single cylinderhaving a first end region, a second end region opposite the first endregion, a single reciprocating piston disposed within the cylinder, anevacuation chamber, an infusion chamber and a transition sectionpositioned between the evacuation chamber and the infusion chamber,wherein the first end region includes a first fluid inlet and the secondend region includes a second fluid inlet; moving the piston within thefirst end region at a first speed, the second end region at a secondspeed, and the transition section region at a third speed, wherein thetransition section is positioned between the first end region of thecylinder and the second end region of the cylinder, wherein the first,the second or both the first and second speeds are greater than thethird speed; accelerating the piston from the third speed to the firstspeed at a first acceleration; and accelerating the piston from thethird speed to the second speed at a second acceleration, wherein thefirst acceleration and the second acceleration are configured to providea continuous output of fluid out of the pump.
 13. The method of claim12, wherein moving the piston further comprises filling the infusionchamber with fluid while simultaneously evacuating fluid from theevacuation chamber.
 14. The method of claim 12, wherein the first,second and third speeds are variable, and wherein the piston adjusts thefirst, second and/or third speeds in response to the output of fluid outof the pump.
 15. The method of claim 12, wherein the transition sectionspans a distance between the first fluid and the second fluid.
 16. Themethod of claim 15, wherein each of the first fluid inlet and the secondfluid include at least one unidirectional valve.
 17. The method of claim12, wherein the distal end region of the infusion catheter includes oneor more fluid infusion ports, and wherein the continuous output of fluidis directed through the one or more infusion ports.
 18. A method ofinfusing fluid into a body lumen, the method comprising: positioning aninfusion catheter adjacent a target site within the body lumen, theinfusion catheter including a distal end region and a proximal endregion, the proximal end region coupled to an infusion pump, wherein theinfusion pump includes: a single cylinder having a first end region, asecond end region and a transition region positioned between the firstend region and the second end region, wherein the first end regionincludes a first inlet and the second end region includes a secondinlet; and a single reciprocating piston disposed within the singlecylinder, the single cylinder having a first transition zone and asecond transition zone; moving the piston within the first end region ata first speed, the second end region at a second speed, and thetransition region at a third speed; accelerating the piston within thefirst transition zone from the third speed to the first piston speed ata first acceleration; accelerating the piston within the secondtransition zone from the third speed to the second piston speed at asecond acceleration; varying the first acceleration and the secondacceleration to maintain a continuous output of fluid out of the pump.19. The method of claim 18, wherein the first, second and third speedsare variable, and wherein the piston adjusts the first, second and/orthird speeds in response to the continuous output of fluid out of thepump.